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Code No: 236AE
JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD
H
B. Pharmacy III Year II Semester Examinations, November/December - 2020
GENERIC DRUG PRODUCT DEVELOPMENT
Time: 2hours Max.Marks:75
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Answer any five questions
All questions carry equal marks
SE
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1. What is Hatch-waxman Act and write its amendments. [15]

D
2. Write the concepts of generic product development. [15]

3. What is process optimization and packaging selection? Explain in detail. [15]

PA
4. Write the steps to design of dosage form to test equivalence to reference drug.
[15]
PE
5. Write method development parameters and give their limits. [15]

6. Write briefly on stability studies at differed conditions. [15]

R
7. How do you ensure invivo test to bioequivalence of a test product. [15]
S
8. Write briefly on eCTD and various modules. [15]

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